Lymphoma, Non-Hodgkin Clinical Trial
Official title:
Large Cell Lymphoma, Pilot Study III
The main purpose of this study is to find out if it is feasible to deliver a multi-agent chemotherapy regimen which features a shorter, more intensive, immunophenotype-directed approach, and includes an intensification phase with hematopoietic stem cell support for children with large cell lymphoma
Secondary objectives will include documenting the toxicity associated with the treatment
regimen, and to estimate the response rates and survival of participants with large cell
lymphoma treated on this protocol.
Patients will be treated with induction, consolidation, and maintenance treatment.
Induction
MIED chemotherapy - High dose methotrexate, ifosfamide, etoposide, and dexamethasone for 2
cycles.
High-dose methotrexate 8 gm/m2 on Day 1 with leucovorin rescue Ifosfamide 2 gm/m2/day on
days 2-4 (total of 3 days) Etoposide (VP-16) 200 mg/m2/day on Days 2-4 (total of 3 days)
Dexamethasone 40 mg/m2/day IV on days 1-4 (given IV or PO daily x 4) Intrathecal MHA, age
adjusted dosages.
Consolidation
COPADM chemotherapy for 2 cycles - cyclophosphamide, vincristine, prednisone, adriamycin,
high-dose methotrexate
COPAM#1 High dose methotrexate (HD MTX) 5 gm/m2 IV over 4 hours on Day 1 with leucovorin
rescue; Doxorubicin 60 mg/m2 IV over 6 hours on Day 2, Vincristine 2.0 mg/m2 (2.0 mg max)
Day 1, Cyclophosphamide 500 mg/m2/day (divided every 12 hours) Days 2-4, Prednisone 60 mg/m2
(divided bid) Days 1-5, Intrathecal MHA, age adjusted dosages.
COPADM#2 - like COPADM#1 except: 1. cyclophosphamide dose increased to 1 gm/m2/day divided
every 12 hours on Days 2-4, and 2. second dose of vincristine given on Day 6.
DAC chemotherapy x 1 cycle - Dexamethasone, cytarabine, and carboplatin
Carboplatin (AUC of 8) Day 1; Ara-C 2 gm/m2/dose q12 x 2 Day 2 Dexamethasone 40 mg/m2/day
Days 1-4; ITMHA dose age adjusted.
Hematopoietic Stem Cell Transplantation - high-dose cyclophosphamide and etoposide
Involved field radiation to the primary tumor will be given over 3-4 weeks. Participants
with CNS disease at diagnosis will also receive cranial irradiation.
Maintenance chemotherapy
Vinblastine 6 mg/m2 IV weekly for one year
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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